Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00159913
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2005-09-08
Brief Title:
A Randomized Double-Blind Placebo-Controlled Study of Sildenafil in Children With Pulmonary Arterial Hypertension
Sponsor:
Pfizers Upjohn has merged with Mylan to form Viatris Inc
Organization:
Pfizer
Study Overview
Official Title:
A Randomized Double-Blind Placebo Controlled Dose Ranging Parallel Group Study of Oral Sildenafil in the Treatment of Children Aged 1-17 Years With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a clinical research study designed to evaluate sildenafil for the treatment of Pulmonary Arterial Hypertension in children aged 1 to 17 years The purpose of the study is to assess the efficacy safety and pharmacokinetics of 16 weeks of chronic treatment with oral sildenafil given in three different doses compared to placebo inactive treatment Efficacy will be measured by exercise and hemodynamics Patients who complete this trial may be eligible to take part in an extension study in which all patients will receive active treatment of sildenafil
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None